Milk of Magnesia

Product NDC: 0121-0431
11-digit product format: 001210431
Labeler code: 0121
Product ID: 0121-0431_57f5d77e-6712-4cd8-8299-3fe42ff67aef
Type: HUMAN OTC DRUG
Nonproprietary name: Magnesium Hydroxide
Dosage form: SUSPENSION
Route: ORAL
Labeler: PAI Holdings, LLC dba PAI Pharma
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1979-09-04
Substance: MAGNESIUM HYDROXIDE
Active strength: 2400 mg/30mL
Pharmacologic classes: Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Milk of Magnesia
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MAGNESIUM HYDROXIDE	2400 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NBZ3QY004S	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
253017	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2de868a0-c652-473c-8b61-636083b7f757	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0121-0431-30	Milk of Magnesia	10 in 1 TRAY	SUSPENSION	10		6
0121-0431-30	Milk of Magnesia	10 in 1 CASE	SUSPENSION	10		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0121-0431-30	ML - Milliliter	0121-0431	8f8054f2-185a-40d8-992f-43c890584ab4	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
MAGNESIUM HYDROXIDE	ACTIVE INGREDIENT	NBZ3QY004S	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
HYDROXIDE ION	ACTIVE MOIETY	9159UV381P	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	MILK OF MAGNESIA SUSPENSION [CARDINAL HEALTH]	4
Magnesium Hydroxide	ACTIVE INGREDIENT	NBZ3QY004S	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
HYDROXIDE ION	ACTIVE MOIETY	9159UV381P	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
CYCLOMETHICONE 4	INACTIVE INGREDIENT	CZ227117JE	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
HYPROMELLOSE 2910 (4000 MPA.S)	INACTIVE INGREDIENT	RN3152OP35	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
POTASSIUM CITRATE	INACTIVE INGREDIENT	EE90ONI6FF	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0121-0431	MILK OF MAGNESIA (MAGNESIUM HYDROXIDE) SUSPENSION [PAI HOLDINGS, LLC]	6	Current NDC, Legacy NDC, 2 package rows	20241121_2de868a0-c652-473c-8b61-636083b7f757.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 37 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	dcab26ff-2c10-4478-90a8-c89d87261bfa	2024-03-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	4d1391da-7874-4a51-a468-2843ecf6f92b	2024-03-18	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	adaea845-e029-422d-a947-d8ce8f5787ed	2024-03-18	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	8b033d56-b95b-4905-9f33-cf2fbd61ce35	2024-03-15	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	CVS Pharmacy	6a97a181-1ec2-473d-a588-db2f2f2f662d	2024-03-14	Warnings	Exact identifier application number: M007
Stool Softener Extra Strength	DOCUSATE SODIUM	CVS Pharmacy	dcd27653-4c81-4630-a8b7-5fb5dc3e976a	2024-03-13	Warnings	Exact identifier application number: M007
EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE	SENNOSIDES	Haleon US Holdings LLC	62544c2f-6e30-4cec-ae63-233715ef0699	2024-03-13	Warnings	Exact identifier application number: M007
Laxative Stool Softener	DOCUSATE SODIUM, SENNOSIDES	CVS Pharmacy	b52181e3-fd84-479e-8590-18619f6c0dae	2024-03-13	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	CVS Pharmacy	5eb047d2-8317-4de3-9268-d206ca039e3d	2024-03-13	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	f77c65b0-3e13-48ce-a2d9-36a9eba1851f	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	849b057a-dc46-423c-a2f4-b01f135a3803	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE CALCIUM	CVS Pharmacy	cf6a31aa-7abc-4040-9a4e-6d3bd0eaf5cf	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	CVS Pharmacy	8d59fa14-fc7c-4146-ba59-c2a907356dd6	2024-03-07	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Costco Wholesale	a19c20bd-84ff-4931-8312-2fbf0400e8e0	2024-03-06	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Care One (Retail Business Services, LLC.)	a1ea0993-2d23-44e3-bc72-e4bf497ab723	2024-03-05	Warnings	Exact identifier application number: M007
Senna Laxative	SENNOSIDES	Care One (Retail Business Services, LLC.)	a5994303-c9d0-4c6f-8eb7-5f364aa6ed0f	2024-03-05	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Care One (Retail Business Services, LLC.)	eb7f3d65-8741-407d-b3f3-1d9dda19684d	2024-03-05	Warnings	Exact identifier application number: M007
Fleet	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC	C.B. Fleet Company, Inc.	f50ba829-16c3-40a7-9822-8d6d00353b33	2024-02-29	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	4ce62421-97e0-4920-9a6d-9fa1f0f93fe4	2024-02-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	851a5dda-e72b-4067-a98f-54d3222f646e	2024-02-23	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NBZ3QY004S	MAGNESIUM HYDROXIDE	1309-42-8	MAGNESIUM HYDROXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
253017	magnesium hydroxide 1200 MG in 15 mL Oral Suspension	PSN	144c7242-4ff9-404a-86bf-48e2871eb0cd	13
253017	magnesium hydroxide 80 MG/ML Oral Suspension	SCD	144c7242-4ff9-404a-86bf-48e2871eb0cd	13
253017	magnesium hydroxide 1200 MG per 15 ML Oral Suspension	SY	144c7242-4ff9-404a-86bf-48e2871eb0cd	13
253017	milk of magnesia 2400 MG per 30 ML Oral Suspension	SY	144c7242-4ff9-404a-86bf-48e2871eb0cd	13
253017	milk of magnesia 400 MG per 5 ML Oral Suspension	SY	144c7242-4ff9-404a-86bf-48e2871eb0cd	13
253017	milk of magnesia 8 % Oral Suspension	SY	144c7242-4ff9-404a-86bf-48e2871eb0cd	13
253017	milk of magnesia 80 MG/ML Oral Suspension	SY	144c7242-4ff9-404a-86bf-48e2871eb0cd	13
253017	magnesium hydroxide 1200 MG in 15 mL Oral Suspension	PSN	2de868a0-c652-473c-8b61-636083b7f757	6
253017	magnesium hydroxide 80 MG/ML Oral Suspension	SCD	2de868a0-c652-473c-8b61-636083b7f757	6
253017	magnesium hydroxide 1200 MG per 15 ML Oral Suspension	SY	2de868a0-c652-473c-8b61-636083b7f757	6
253017	milk of magnesia 2400 MG per 30 ML Oral Suspension	SY	2de868a0-c652-473c-8b61-636083b7f757	6
253017	milk of magnesia 400 MG per 5 ML Oral Suspension	SY	2de868a0-c652-473c-8b61-636083b7f757	6
253017	milk of magnesia 8 % Oral Suspension	SY	2de868a0-c652-473c-8b61-636083b7f757	6
253017	milk of magnesia 80 MG/ML Oral Suspension	SY	2de868a0-c652-473c-8b61-636083b7f757	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0121-0431-30	00121043130	10 TRAY in 1 CASE (0121-0431-30) / 10 CUP, UNIT-DOSE in 1 TRAY / 30 mL in 1 CUP, UNIT-DOSE	10 tray	1979-09-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Milk of Magnesia	Cardinal Health 107, LLC	2026-06-05	HUMAN OTC DRUG LABEL	14
Milk of Magnesia	PAI Holdings, LLC dba PAI Pharma \| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma	2026-01-22	HUMAN OTC DRUG LABEL	7
Milk of Magnesia	A-S Medication Solutions	2021-03-01	HUMAN OTC DRUG LABEL	6